Module 15 Presentations

15/04/2024

Planning

Claims, Risks & Benefits Reimbur sement

De Novo 510(k) PMA

I nvest. D evice E xempt

Q-Subs:

Use of OUS data

The Organisation for Professionals in Regulatory Affairs

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FDA Guidance Approach Helps Clinical Strategic Thinking: Least Burdensome Provisions

1. The right information should be provided at the right time to address the right questions

2. Regulatory approaches should be designed to fit the technology , taking into account its unique innovation cycles, evidence generation needs, and timely patient access 3. FDA intends to leverage data from other countries and decisions by, or on behalf of, other national medical device regulatory authorities to the extent appropriate and feasible

https://www.fda.gov/regulatory information/search-fda-guidance documents/least-burdensome provisions-concept-and-principles Similar to Europe on Clinical Data, but not same on approach

The Organisation for Professionals in Regulatory Affairs

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